Restoration of dental, oral and craniofacial (DOC) tissues lost to disease, injury or congenital disorders is a major goal of oral reconstructive therapy. Tissue engineering (TE) and regenerative medicine (RM) offer strong potential to yield more predictable, less invasive and personalized treatments for patients. The goal of this Resource Center (RC) is to transform the treatment of DOC deformities due to disease or injury through the development and translation of clinically-relevant TE/RM technologies. Our vision to achieve this goal is to integrate advances in life science and engineering technologies to solve clinically-defined problems in an environment having a translational infrastructure. Fulfillment of this vision will enable dentistry to be transformed, will establish Michigan as a national leader i regenerative DOC therapies, and will serve as an economic engine for the region. To advance translation of TE/RM technologies to the clinical arena and fulfill the goals of this RFA, a shift n thought regarding the practice of TE/RM is required. Towards this end, we will establish an interactive, multidisciplinary team comprised of investigators at Michigan, the Clinical Practice Community and Harvard/Wyss Institute. This team will develop an organizational structure and operational procedures for establishing a centralized RC for identifying the most promising TE/RM technologies for clinical application. By establishing multidisciplinary teams working toward a common vision, our RC will enable technologies to progress through the translational pipeline. To achieve this vision, in this planning grant, we will: 1) Develop an organizational structure to select regenerative strategies to translate to clinical practice. The RC will leverage existing excellence at the University of Michigan, Clinical Practice Key Opinion Leaders (KOLs) and Harvard/Wyss Institute, along with Michigan's translational infrastructure in TE/RM and industrial partners to form a coordinated team. This team will be dedicated to selecting the most scientifically sound, clinically and commercially applicable strategies for the regeneration of DOC tissues. 2) Develop a support and infrastructure team for technical advancement of selected strategies. The RC will orchestrate high quality technical support and a research infrastructure dedicated to guiding TE/RM investigators at Michigan and other RCs on how to test and validate technologies, standardize procedures and compare to existing technologies, and define appropriate endpoints and functional outcomes. 3) Develop teams and operating procedures to support the clinical translation of selected TE/RM technologies. We will organize: a) the application of clinically relevant pre-clinical animal models that recapitulate human disease and injury conditions; b) manufacturing protocols; c) FDA regulatory expertise and protocol development for Phase I/II trials and d) clinical DOC expertise for clinical practice translation.